Development and validation of a reversed phase HPLC-UV method for abemaciclib-related substance detection in bulk drugs.

Abemaciclib is an effective selective cyclin-dependent kinases 4 and 6 inhibitor for cancer therapy. The abemaciclib-related substances influence its efficacy and safety, and are important in process preparation studies and quality control. Thus, a reversed phase HPLC method was developed and validated for the detection of related substances in its bulk drug. The separation of abemaciclib and related substances was performed on a Phenomenon Gemini C18 column (4.6 mm×250 mm, 5 μm) with a flow rate of 1.0 mL min . The ultraviolet detection wavelength was 280 nm. Mobile phase A was composed of a mixed solution of aqueous solution and acetonitrile (9:1, volume/volume). The aqueous solution (pH 2.5) contained 0.025-mM potassium dihydrogen phosphate solution and 0.4% triethylamine. Mobile phase B was composed of acetonitrile. This novel method exhibits good system suitability, specificity, precision, stability, linearity (0.1-20 μg mL ), repeatability and durability. Among abemaciclib and related substances, the lowest limit of detection and quantitation were 0.02 and 0.06 μg mL , respectively, for abemaciclib. The recovery rates for related substances were above 95%. In addition, a novel degradation product was found during the process. In summary, a reliable reversed phase HPLC method was developed for abemaciclib-related substances detection in bulk drugs. This article is protected by copyright. All rights reserved.